Day: January 26, 2023

Clinical trial sponsors are required to create and implement trial-specific “Race and Ethnicity Diversity Plan” for patient recruitment intended to promote diversity of the subject populations in all stages of their clinical trials. However, these plans have had limited impact on most clinical trials as shown by review of the patient populations included in clinical … Read more

This week’s FDA guidance on the conduct of clinical trials involving cannabis and its derivatives reminds the developers of two critical aspects of the regulation of such products by the FDA and confirms the associated regulatory processes. First, cannabis products containing greater that 0.3 percent delta-9 tetrahydrocannabinol (THC) are still federally regulated as controlled substances … Read more